Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today

Mon, 10/18/2010 - 6:33am

THOUSAND OAKS, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today's meeting of the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

"This advisory committee meeting is a valuable forum for the FDA, Amgen and the nephrology community to review the results from TREAT, which further inform use of ESAs in patients with chronic renal failure who are not on dialysis," said Reshma Kewalramani, M.D., FASN, executive director, Global Development at Amgen. "We look forward to sharing our analyses of TREAT and describing proposed label changes that will help guide nephrologists in focusing their use of ESA therapy on patients most likely to benefit."

TREAT, the largest study of ESA use in CRF patients to date, is a randomized, double-blind, placebo-controlled, Phase 3 study of patients with moderate kidney dysfunction who were not on dialysis, had moderate anemia and type-2 diabetes and were treated to a hemoglobin target of 13 g/dL, a higher level than recommended in the current approved ESA label. The study did not meet its endpoints of demonstrating a reduction in all-cause mortality, cardiovascular morbidity or end-stage renal disease and showed an increased risk of stroke in the Aranesp (darbepoetin alfa) arm, among other key findings.

The results from TREAT provide important information about the cardiovascular risks of treating CRF patients with ESAs to a hemoglobin target of 13 g/dL or greater. Cardiovascular risks have been reflected in the boxed warning of the FDA-approved ESA labels since 2007 and, in December 2009, Amgen further strengthened the





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